Regulatory Affairs Specialist

RAQA Specialist (m/f/d) – Regulatory Affairs & Quality Systems

As a RAQA Specialist, you will support Regulatory Affairs and Quality activities for our business across Germany, Switzerland, and Austria (GSA), with a strong focus on Swiss registration requirements. You will help ensure compliance with MDR 2017/745 and applicable Swiss legislation (e.g., MedDO), drive product registration and maintenance activities (including Swissmedic/Swiss regulatory applications such as Swissdamed), and support continuous improvement of Quality Management System (QMS) processes. Collaborating with cross-functional stakeholders and global teams, you will contribute to a compliant, efficient, and continuously improving RAQA organization.

Responsibilities

• Support product registration and lifecycle maintenance activities for Switzerland (and GSA as applicable), including preparation, review, and maintenance of regulatory documentation and registrations.
• C...